Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this study is to compare the effects of exercise with the effects of relaxation training on physical function (how well participants perform normal daily activities) and symptoms related to your cancer diagnosis (such as tiredness, pain, and nausea).
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
If you are in the exercise group, you will receive a doctor's recommendation to exercise (in-person advice and letters), newsletters on behavior change methods, resistance bands, a pedometer, and telephone counseling. A pedometer is a small device used to measure the number of steps you take.
If you are in the relaxation group, you will receive a doctor's recommendation to practice relaxation training (in-person advice and letters), newsletters on behavior change methods, written and video instructions for doing the relaxation techniques, and telephone counseling.
If you are in the Exercise Group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage IV or recurrent colorectal cancer
- •Age >/= 18 years
- •ECOG performance status of 0 -1
- •Able to communicate in English or Spanish
- •Able to give informed consent
- •Adequate organ function -Total bilirubin < 1.5 x the institutional upper-normal limits (IUNL); AST (SGOT) and/or ALT (SGPT) < 2.5 x IUNL; Patients with liver metastasis AST/ (SGOT) and/or ALT (SGPT) < 5 x IUNL
- •Adequate bone marrow function: - Absolute neutrophil count > 1,000/microLiters; Platelets > 50,000/microLiters
- •Able to ambulate without assistance
- •Has access to a telephone in order to receive pre-recorded telephone messages and for multiple counseling sessions.
排除标准
- •Major surgery in the past 8 weeks
- •Medical contraindications to home-based exercise as defined by the treating physician
- •Symptomatic Bone Metastases
- •Unstable Angina (current symptomatic angina at time of enrollment)
- •Class III/IV heart failure according to NYHA classification system
- •Pulmonary conditions that require oxygen
- •Unable to ambulate without assistance (cane, walker, etc)
- •Exercising at a moderate-vigorous intensity for 150 minutes or more per week, exercising at a vigorous intensity for more than 20 minutes on 3 or more days per week, or performing resistance exercises for more than 20 minutes per day on two or more days per week for 3 months or more.
研究组 & 干预措施
Exercise Program
Arm I (exercise program): Oncologist advice; Resistance bands & pedometer with written/DVD instructions for resistance exercise twice a week for 16 weeks. Brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day. Monthly newsletters; Telephone counseling weekly for 4 weeks then monthly for 12 weeks; and tailored message telephone prompts once every 2 weeks during last 12 weeks of the study intervention.
干预措施: Questionnaire administration (Other)
Exercise Program
Arm I (exercise program): Oncologist advice; Resistance bands & pedometer with written/DVD instructions for resistance exercise twice a week for 16 weeks. Brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day. Monthly newsletters; Telephone counseling weekly for 4 weeks then monthly for 12 weeks; and tailored message telephone prompts once every 2 weeks during last 12 weeks of the study intervention.
干预措施: Exercise Program (Behavioral)
Exercise Program
Arm I (exercise program): Oncologist advice; Resistance bands & pedometer with written/DVD instructions for resistance exercise twice a week for 16 weeks. Brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day. Monthly newsletters; Telephone counseling weekly for 4 weeks then monthly for 12 weeks; and tailored message telephone prompts once every 2 weeks during last 12 weeks of the study intervention.
干预措施: Telephone-based intervention (Behavioral)
Exercise Program
Arm I (exercise program): Oncologist advice; Resistance bands & pedometer with written/DVD instructions for resistance exercise twice a week for 16 weeks. Brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day. Monthly newsletters; Telephone counseling weekly for 4 weeks then monthly for 12 weeks; and tailored message telephone prompts once every 2 weeks during last 12 weeks of the study intervention.
干预措施: Counseling intervention (Other)
Relaxation Intervention
Arm II (relaxation program): Oncologist advice; Written/CD audio instructions on diaphragmatic breathing and guided imagery. Practice relaxation techniques for 15 minutes/day, 5-7 days/week, for 16 weeks. Monthly newsletters, telephone counseling, and tailored-message telephone prompts as in arm I.
干预措施: Telephone-based intervention (Behavioral)
Relaxation Intervention
Arm II (relaxation program): Oncologist advice; Written/CD audio instructions on diaphragmatic breathing and guided imagery. Practice relaxation techniques for 15 minutes/day, 5-7 days/week, for 16 weeks. Monthly newsletters, telephone counseling, and tailored-message telephone prompts as in arm I.
干预措施: Counseling intervention (Other)
Relaxation Intervention
Arm II (relaxation program): Oncologist advice; Written/CD audio instructions on diaphragmatic breathing and guided imagery. Practice relaxation techniques for 15 minutes/day, 5-7 days/week, for 16 weeks. Monthly newsletters, telephone counseling, and tailored-message telephone prompts as in arm I.
干预措施: Questionnaire administration (Other)
Relaxation Intervention
Arm II (relaxation program): Oncologist advice; Written/CD audio instructions on diaphragmatic breathing and guided imagery. Practice relaxation techniques for 15 minutes/day, 5-7 days/week, for 16 weeks. Monthly newsletters, telephone counseling, and tailored-message telephone prompts as in arm I.
干预措施: Relaxation Program (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: 3 year study period
Program and assessment implementation
时间窗: 3 year study period
Patient adherence to behavioral recommendations
时间窗: Up to 20 weeks
Patient retention
时间窗: 3 year study period
Effect size of the exercise intervention on physical function
时间窗: Up to 20 weeks
次要结局
- Effect size of the exercise intervention on symptoms and quality of life(Up to 20 weeks)